The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni™ (sofosbuvir and ledipasvir) should be extended to 12- and 24-week curative treatment durations.

The Fair Pricing Coalition (FPC) today applauded the October 10, 2014, U.S. Food and Drug Administration (FDA) approval of Harvoni, a combination tablet containing the direct acting antivirals (DAAs) sofosbuvir and ledipasvir for the curative treatment of genotype 1 hepatitis C, and called upon Gilead Sciences to establish a uniform price per cure, regardless of the length of therapy.

The FPC, a coalition of HIV and viral hepatitis treatment activists, recognizes the significant advance in treatment success and convenience of Harvoni, but is disappointed at the Wholesale Acquisition Cost (WAC) of $1,125 per once-daily tablet, or $63,000, $94,500, and $189,000 for an 8-, 12-, and 24-week course of treatment, respectively.

The FPC maintains that these costs, particularly for the 12- and 24- week courses of treatment, are exorbitant. Since they are now published, however, FPC concludes that the WAC of $63,000 for eight weeks of Harvoni, which is projected to be the most common duration of treatment as more people living with genotype 1 hepatitis C learn of their infection and seek care, should be made the uniform cost per cure, regardless of the length of therapy.

Harvoni’s FDA approval follows that of Sovaldi® (sofosbuvir) on December 3, 2013, the price of which was denounced by FPC. The $84,000 WAC ($1,000 per pill) of Sovaldi has since brought rebukes from insurers, activists, government officials, health care providers, and people living with hepatitis C.

While Gilead has contended that the total price for a course of treatment with a Sovaldi-containing regimen was a modest increase compared with previous standards of care, this is an invalid argument based on the incorrect premise that these regimens were appropriately priced to begin with. So, although an eight-week course of Harvoni will result in a lower cost-per-cure than previous regimens, the $1,125 WAC per pill means that coverage for the 50 percent or more of people living with genotype 1 hepatitis C who require 12 or 24 weeks of therapy will be unreasonably costly and therefore potentially unattainable.

“Harvoni is a remarkable breakthrough in hepatitis C treatment,” explained FPC Co-Chair Lynda Dee. “It is easy to take, is associated with cure rates between 94 and 99 percent, is safe and effective in advanced liver disease, is much less toxic than older regimens, and has a manageable drug interaction profile. Yet its price sours our appreciation of these long-awaited agents, particularly now that we have examples that curative treatment is inaccessible to many because of out-of-control escalator drug pricing.”

Gilead’s pricing of Sovaldi, and now Harvoni, puts these medications on a par with the pricing of pharmaceuticals that are much more costly to manufacture and often for rare diseases, despite the fact that Sovaldi and Harvoni are relatively inexpensive to produce, and that at least 3.5 million people are estimated to be living with hepatitis C in the United States. These costs are putting unprecedented pressure on public and private insurers, and stripping patients and providers of the required autonomy to make treatment decisions based on need.

The FPC recognizes that Gilead Sciences is maintaining their free medications program for low-income, uninsured patients, and expanding subsidies that greatly minimize out-of-pocket expenditures, such as co-payments and co-insurance costs, associated with the placement of Harvoni and Sovaldi in specialty drug tiers. Yet these programs are unable to address all disparities of access to treatment due to excessive pricing, resulting in a two-tiered system of care based on insurance coverage and ability to pay.

“Many resource-constrained programs, such as Medicaid, have only been covering Sovaldi-containing regimens for patients with advanced liver disease, despite the fact that people with early stages of disease can transmit the virus to others and may suffer health consequences if treatment is delayed,” said Murray Penner, FPC Co-Chair. “People living with hepatitis C who seek access to these medications are also being required to undergo degrading evaluations related to drug and alcohol use, factors which have not been scientifically substantiated as determinants of the success or failure of treatment. It remains unclear if the reduced cost associated with eight weeks of Harvoni treatment will mollify these programs and we fear these restrictions will be extended, particularly for those requiring 12 or 24 weeks of treatment.”

“A remarkably safe, effective, and easy-to-take tablet means that if it is financially accessible to the many millions of people who desperately need it, we can actually imagine eliminating this insidious disease nationally and globally,” said Dee. “Gilead has failed to comprehend that pricing its curative treatments beyond what the market can bear is a shortsighted business tactic and a failed public health opportunity, both to the detriment of people living with hepatitis C.”

Discriminatory practices by Qualified Health Plans (QHPs) in the health insurance marketplaces, exorbitant drug pricing by the pharmaceutical industry, and a lack of clear guidance from the federal government regarding the legality of co-payment assistance programs for QHP beneficiaries are proving to be major barriers to affordable treatment for HIV and hepatitis C, according to a new policy guide produced by the Fair Pricing Coalition (FPC).

“The QHPs mandated by the Affordable Care Act are good news for many people living with HIV and/or hepatitis C, as it means they can’t be denied health insurance, because of pre-existing conditions,” explained FPC Co-Chair Lynda Dee. “This ensures the provision of essential health benefits, including important primary care services, access to specialists, and prescription drug benefits.”

“However, many plans are proving financially disastrous for people living HIV, hepatitis C, and other chronic diseases,” Dee added. “This situation is made worse by high drug prices being set and increased annually by manufacturers, along with an inexcusable lack of direction from the U.S. Department of Health and Human Services regarding co-pay assistance programs for people receiving care under ACA-mandated plans.”

Some health insurance companies are not including certain standard-of-care HIV medications in their formularies, essentially circumventing the non-discrimination backbone of ACA.

Many QHPs are placing prescription medications for HIV and hepatitis C in “specialty drug” tiers (Tier 4 or 5), which impose extremely high out-of-pocket costs.

High prices of drugs used to treat HIV and hepatitis C are a key driver of QHPs placing standard-of-care medications in the highest tiers, resulting in prohibitive out-of-pocket costs.

QHPs are failing to be transparent regarding their drug formularies and the associated cost sharing, thereby prohibiting people living with HIV and/or hepatitis C from making educated plan choices.

Some manufacturers and not-for-profit payers have indicated that they are unwilling to extend their co-payment assistance programs to QHP beneficiaries because of conflicting government guidance.

“These are major barriers to life-saving treatment, when in fact we need to be making access to affordable treatment as easy as possible,” said Tim Horn, an FPC member. “Nationally, only 25 percent of people living with HIV are receiving HIV treatment and keeping the virus in their blood in check. This is essential in terms of protecting their own health and preventing ongoing transmission of the virus. We need to get more people on treatment, not fewer, which won’t be possible if they cannot afford their costly medications.”

Among the possible short- and long-term solutions offered by the FPC:

Require access to all U.S. Department of Health and Human Services (HHS)- preferred and HHS-alternative antiretrovirals for HIV and all FDA-approved treatments for hepatitis C.

Monitor tiering of HIV and hepatitis C drugs for discriminatory practices, such as placing all recommended treatment options on the highest cost-sharing or specialty tiers.

Mandate QHP benefits and drug formulary transparency.

Confirm Secretary of Health Kathleen Sebelius’ indication that manufacturers and non-profit payers may help defray out-of-pocket costs for medications under ACA through co-payment assistance programs.

Lower the out-of-pocket spending caps for individuals and families with incomes up to 250 percent of the federal poverty level.

Insist that insurance companies include HIV and hepatitis C expertise on their pharmacy and therapeutics committees or that they consult disease experts regarding formulary and tiering decisions.

“The problems outlined in the policy report are not insurmountable,” said Dee. “The FPC believes that the Affordable Care Act, while not perfect, has tremendous potential to redress disparities for U.S. residents whose access to healthcare has previously been at the whim of conflicting political and economic forces. This applies not only to HIV/AIDS and viral hepatitis, but also to many other chronic, debilitating, and costly health challenges beyond the capacity of individuals to manage on their own.”

The FPC supports urgent attention to these matters for all U.S. residents at this moment of new hope for achieving universal, affordable, quality health care.

The Fair Pricing Coalition (FPC), founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals.

“This is a long-anticipated addition to the options available to people living with HIV/AIDS and their healthcare providers”, said Lynda Dee, FPC spokesperson. “However, in pricing the new drug more than 35% above the $21,000 per year WAC price of its own best-selling single-tablet regimen, Atripla™, Gilead has created an environment of restricted access and financial hardship for patients impacted by current dire economic conditions and US healthcare costs and whose very lives depend on access to more convenient treatments,” Dee added.

Gilead appears to be pricing cobicistat, its own booster component of Stribild™, comparably with Abbott Laboratories’ Norvir™ which includes Abbott’s unconscionable 400% price increase while its closest competitor Merck & Co.’s integrase inhibitor Isentress™, plus Truvada™ needs no booster and has an annual WAC price of $26,200. Thus, Stribild’s™ booster component cobicistat is more like excess baggage than an achievement worth $2,000 above the only other approved integrase inhibitor combination. There may also be a greater risk of kidney side effects with Stribild™ than with the Merck integrase inhibitor combination.

“Gilead asked for community input in setting the price of its new product, and invited the FPC to the negotiating table in June for discussions,” said Dee. “We thought we had reached a reasonable understanding with Gilead, but evidently the company is more interested in filling its coffers than in reasonable and fair pricing. I’m shocked at the price they have set, and would call this a betrayal of the spirit of our negotiations“, she added. “We will now consult with our community partners, government allies as well as public and private payers to determine the best course of action to take,” she concluded.